1. Field of the Invention
The present invention relates generally to the structure and use of surgical instruments. More particularly, the present invention relates to a device and method for introducing a fluid, such as contrast medium, to a body duct, such as the cystic duct.
Cholangiography is a procedure for the X-ray of a patient's bile duct which is commonly performed to locate duct stones during surgical gallbladder removal. The presence of gallstones in the biliary ducts, particularly the common bile duct, is a painful and potentially fatal condition which exists in a significant percentage of patients who have undergone gallbladder removal. Surgical exploration of the common bile duct, however, is itself a relatively risky procedure which is associated with significant morbidity. Thus, the ability to locate the presence of gallstones by cholangiography is of significant benefit to the patient.
Surgical gallbladder removal, referred to as cholecystectomy, is most commonly performed as an open surgical procedure through a major incision in the patient's abdomen. After the gallbladder is removed, and the cystic duct ligated, a flexible catheter is introduced through a small incision in either the cystic duct or the common bile duct. A suitable contrast medium may then be introduced through the catheter to permit X-ray detection of any gallstones which may be present in the ducts.
Laparoscopic surgical removal of the gallbladder is becoming increasingly popular. Laparoscopic surgery is performed through small incisions in the patient's abdomen allowing the necessary surgical instruments to be introduced through a tube, such as a cannula, while the physician observes manipulation of the instruments through a laparoscope. Such laparoscopic surgery offers significant advantages over conventional "open" cholecystectomy. In particular, the laparoscopic cholecystectomy is usually less traumatic, requires a shorter recovery time, and is significantly less costly than the corresponding open surgical procedure.
The performance of cholangiographic detection of gallstones in the bile ducts following a laparoscopic cholecystectomy, however, is problematic. Access to the cystic duct and the common bile duct is necessarily more limited than in the open surgical procedure, and the introduction of a catheter to either of the ducts is difficult to achieve. While the use of a catheter and syringe for introducing contrast medium is possible, it is difficult to access, introduce, and seal the penetration to achieve effective cholangiography.
For these reasons, it would be desirable to provide improved devices and methods to facilitate the introduction of fluids, such as contrast media, to body ducts, such as the biliary ducts. It would be particularly desirable to provide a single instrument having the combined capabilities of capturing and immobilizing the target duct as well as penetrating a wall of the duct to introduce the fluid into the duct lumen. Such devices should be easy to manipulate, preferably allowing all manipulations to be performed with a single hand, and should be suitable for laparoscopic and other "least invasive surgical" procedures. The device and method of the present invention should further assure that the fluid is introduced accurately within the duct lumen and that the fluid is able to be transported to other regions of the duct system. The device should also cause minimum damage to the duct which is being treated.
2. Description of the Background Art
Catheters and cannulas for introducing contrast media to a patient's bile ducts following open surgical gall bladder removal are described in the patent and medical literature. See, for example, U.S. Pat. Nos. 4,747,823; 4,547,187; 4,306,566; 4,044,757; 4,044,758; and 3,918,456. Devices for clamping the cystic duct in conjunction with the open surgical introduction of a cholangiogram catheter are described in U.S. Pat. Nos. 4,817,604 and 4,792,330.